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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, cautery, radiofrequency, ac-powered
510(k) Number K934320
Device Name MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
Applicant
MENTOR O & O, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Applicant Contact RICHARD L FOLLETT
Correspondent
MENTOR O & O, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Correspondent Contact RICHARD L FOLLETT
Regulation Number886.4100
Classification Product Code
HQR  
Date Received09/03/1993
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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